Blog
What industry can learn from RWE demonstration projects
As global regulatory and health technology assessment (HTA) bodies continue to iterate on ...
Blog
RWE guidance watch: EMA real world evidence guidance on registry-based studies
UPDATE: As of November 2021, EMA has now issued its final guideline on registry-based ...
Blog
New Gartner survey suggests synthetic data is the future of data sharing
By Dr. Khaled El Emam Posted On: November 9th, 2021
Blog
COVID-19 vaccine rollout shows real-world evidence was ready for the spotlight
Just 10 months since administration of the first COVID-19 vaccine dose, hundreds of ...
Presentation
Synthetic Data Generation for Rare Disease Research
Blog
Join primary and real-world data to generate patient-relevant RWE across the product lifecycle: Q&A with Dr. Javier Jimenez of Syneos Health
Understanding how medical interventions impact patients has always been a top priority ...
Presentation
Measuring Re-identification Risk for Synthetic and Anonymized Data
Blog
Ten Recommendations for Regulating Non-identifiable Data
There is considerable activity today in regulatory development and updates around the ...
Presentation
Synthetic Data
Blog
ICPE Research Spotlight 2021: Part II: Forging methods to advance principled database epidemiology
This year at ICPE All Access, Aetion’s scientific research was represented across ...
Presentation
Practical Mechanisms for Generating Anonymous Data
Presentation
Ten Recommendations For Regulating De-identification
Blog
ICPE Research Spotlight 2021: Part I: Findings from Aetion-FDA research collaboration to advance understanding of COVID-19 with RWE
This year at ICPE All Access, Aetion’s scientific research is represented across ...
Blog
RWE to inform value decision-making: Learnings from ICER’s 24-month reassessment pilot
In its 2020 Value Assessment Framework, the Institute of Clinical and Economic Review ...
Article
Could Synthetic Data be the Future of Data Sharing?
This article in CPO Magazine explores the rise of synthetic data generation (SDG) as a ...
Blog
Patient voice in RWE: Generating evidence that will impact payer and HTA decision-making
With the rise of patient-centered medicine and accelerated approvals, health technology ...
FDA Decision Alert
CDER-Approved NDA for LUMAKRAS™ (sotarasib)
On May 28, 2021, FDA granted Accelerated Approval to Amgen’s LUMAKRAS™ (sotarasib) for ...
FDA Decision Alert
CBER-Approved sBLA for KEDRAB® (rabies immune globulin (human))
On May 17, 2021, FDA approved an sBLA for Kamada’s KEDRAB® (rabies immune globulin ...
Blog
RWE Guidance Watch: IMPACT HTA publishes recommendations on the use of RWE in HTA
As researchers await comprehensive guidance on the use of real-world evidence (RWE)—and ...
Blog
An update on efforts to standardize and democratize RWE: Q&A with Dr. Nirosha Mahendraratnam Lederer
As real-world evidence (RWE) adoption continues to ramp up across health care, ...
Blog
Research spotlight: Gilead Sciences and Aetion use RWE to assess the comparative effectiveness of remdesivir for COVID-19
As COVID-19 continues to evolve, frontline health care workers are eager for real-world ...
FDA Decision Alert
CBER-Approved BLA for ABECMA® (idecabtagene vicleucel)
On March 26, 2021, FDA approved Celgene’s BLA for ABECMA® (idecabtagene vicleucel) for ...
FDA Decision Alert
CDER-Approved sBLA for ERBITUX® (cetuximab)
On April 6, 2021, FDA approved a new biweekly dosing regimen for Eli Lilly’s ERBITUX® ...
Blog
Using RWE to characterize diseases as novel treatments become available: Q&A with Dr. Maria Schneeweiss
As novel therapies come to market, especially in disease areas that aren’t as well ...